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The Impact of Risk Management on CAPA

If you’re in the business of developing medical devices, then risk and risk management become synonymous with daily operations. Your overall task is to bring a medical device to market that not only provides a needed function to a patient but is also proven to be safe and effective to use. A product that may be used by someone who is near and dear to you, too. Risk management is a process that is very much here to stay in the medical device industry. On the product side of risk, ISO 14971 continues to be the cornerstone of identifying, assessing, evaluating, and controlling risks as a means to ensure medical devices are as safe and effective as possible. FDA also works to ensure stronger risk management by requiring manufacturers of medical devices to have clearly documented procedures for corrective action and preventive action (CAPA). So how does CAPA play a role in product risk management? Many CAPAs will impact medical device products in some way, shape, or form. Whether addressing a design issue, how the device is used, dealing with specifications, or manufacturing processes, CAPA actions need to consider and address risk management. And it’s not enough to just check a box on a CAPA form. Addressing risk requires reviewing documented product risk management to determine if the issues within the CAPA are defined accurately. If not, then update your risk management accordingly. From a product side of risk management, this interaction with CAPA is so import...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news

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Source: Journal of the American Academy of Physician Assistants - Category: Primary Care Tags: Editorial Source Type: research
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Source: Journal of the American Academy of Physician Assistants - Category: Primary Care Tags: Pharmacology Consult Source Type: research
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Source: Journal of the American Academy of Physician Assistants - Category: Primary Care Tags: CME: Women's Health Source Type: research
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Source: Journal of the American Academy of Physician Assistants - Category: Primary Care Tags: CME: Primary Care Source Type: research
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Source: Journal of the American Academy of Physician Assistants - Category: Primary Care Tags: Post-Test Source Type: research
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Source: Journal of the American Academy of Physician Assistants - Category: Primary Care Tags: Case Report Source Type: research
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Source: Journal of the American Academy of Physician Assistants - Category: Primary Care Tags: Review Article Source Type: research
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Source: Journal of the American Academy of Physician Assistants - Category: Primary Care Tags: Original Research Source Type: research
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Source: Journal of the American Academy of Physician Assistants - Category: Primary Care Tags: Special Article Source Type: research
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Source: Journal of the American Academy of Physician Assistants - Category: Primary Care Tags: Quick Recertification Series Source Type: research
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